The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

Sponsor
Qilu Hospital of Shandong University
Study ID
NCT05527444
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 150 mg/ml — DRUG
    Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24
  • Adalimumab Ab — DRUG
    adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24
  • NSAID — DRUG
    stable dose
  • Thalidomide Pill — DRUG
    If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.

Study Details

The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.

Key Dates

Start date
Mar 15, 2022
Status verified
Nov 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized-SEC group
    actived AS patients naïve to ADA and SEC
  • Experimental: Randomized-ADA group
    actived AS patients naïve to ADA and SEC
  • Experimental: Non-Randomized-SEC group
    AS patients who previously had inadequate response to ADA
  • Experimental: Non-Randomized-ADA group
    AS patients who previously had inadequate response to SEC

Primary Outcome Measure

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Baseline and Week 12 ]

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